ISO 8536-11:2015

Overview

ISO 8536-11:2015 - Infusion equipment for medical use - Part 11 provides requirements for sterilized infusion filters for single use designed to be used with pressure infusion equipment up to 200 kPa (2 bar). The standard covers design, materials, physical, chemical and biological requirements, packaging and labelling for single-use infusion filters connected to fluid lines defined in ISO 8536‑8. It explicitly does not specify filter effectiveness for particle or germ removal.

Keywords: ISO 8536-11:2015, infusion filters, pressure infusion equipment, single use, sterilized, medical device standards

Key topics and technical requirements

• Scope and limits
  • Applies to sterilized single‑use infusion filters used up to 200 kPa (2 bar).
  • Excludes performance claims about particle/germ separation.
• Design
  • Housing must include a venting system to help prevent filter blocking by air bubbles.
• Materials
  • Materials must meet relevant physical, chemical and biological criteria referenced in the standard.
• Physical requirements
  • Transparency: filter housing must be transparent so the air–water interface is detectable.
  • Particulate contamination: manufacturing must minimize particles; inner surfaces smooth and clean.
  • Tensile strength: withstand a static longitudinal tensile force of at least 15 N for 15 s.
  • Leakage: housing and membrane connections must be impermeable; no air/water leakage under test conditions.
  • Connectors: adapters with female and/or male conical fittings per ISO 594‑2.
  • Protective caps: refer to ISO 8536‑4 requirements.
• Chemical & biological
  • Sterilization must be validated.
  • Assessment for freedom from pyrogens and haemolytic constituents (guidance from ISO 10993‑4 and ISO 8536‑4).
• Packaging & labelling
  • Unit labelling must include manufacturer, product description, sterility symbol, single‑use indication, lot (LOT), expiry date, and the wording “Safe for use with pressure infusion equipment” plus the designation (e.g., ISO 8536‑11 - IF - P). Graphical symbols per ISO 15223‑1 and ISO 7000 (symbol 2725) may be used.

Applications and users

• Manufacturers of infusion filters and pressure infusion sets - for design, testing and compliance.
• Quality, regulatory and clinical engineering teams - for device specification, conformity assessment and procurement.
• Hospitals and healthcare providers - to verify labeling, compatibility and safe use with pressure infusion apparatus.
• Test laboratories and sterilization service providers - for physical, chemical and biological testing.

Related standards

• ISO 8536 series (Parts 1–14) - related infusion equipment requirements
• ISO 8536‑4 - Infusion sets and applicable test methods
• ISO 594‑2 - Conical (Luer) fittings
• ISO 15223‑1 - Symbols for medical device labelling
• ISO 10993‑4 - Biological evaluation (blood interactions)
• Note: some references indicate transition to ISO 80369‑7 for specific connector standards.

For manufacturers and compliance teams, ISO 8536-11:2015 is essential for ensuring single‑use infusion filters are safe, labelled correctly and compatible with pressure infusion equipment up to 2 bar.